A randomised controlled study with whole-cell or acellular pertussis vaccines in combination with regular DT-IPV vaccine and a new poliomyelitis (IPV-Vero) component in children 4 years of age in the Netherlands.

In this study the immunogenicity of the whole cell pertussis vaccine and 3 acellular pertussis vaccines is compared after administration as a booster in children 4 years of age. The occurence of adverse events within 1 week after vaccination and the persistence of antibody levels after 2 years are also investigated.

After vaccination with the ACV’s almost all the titers are high against the different pertussis components and generally reflect the composition of these components present in the vaccines. The titers are comparable with those observed in other trials with these vaccines. After vaccination with the WCV the antibody levels are lower as found for the ACV's and more diverse, varying from good to low for the different pertussis vaccine antigens. A drawback of the WCV is the rate of adverse events which is in general 4 times as much as observed for the ACV's, although the adverse reactions are mostly mild and of limited duration. 2 Years after the booster vaccination almost all pertussis antibody titers have decreased to background level.

To compare the immunogenicity of the Dutch whole cell vaccine versus 3 acellular pertussis vaccines administered as a booster at 4 years of age by measuring the antibody levels in serum after 1 month and 2 years.

Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.

A total of 180 children 4 years of age were divided over 5 groups.

1. DT-IPV vaccine administration as controlgroup (N=45)

2. DTwP-IPV (N=44)

3. DT-IPV and aP from SKB (N=44)

4. DT-IPV and aP from Wyeth-Lederle (N=23)

5 DT-IPV and aP from Pasteur-Merieux (N=24).

Blood samples were taken just before the vaccination, 4-6 weeks and 2 years postvaccination.